Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

Phase 3

Terminated

• Conditions: Diverticulitis
• Interventions: Drug: Placebo; Drug: Mesalazine

• Registration Number: NCT00695643
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

The purpose of the study is to determine whether mesalazine granules compared to placebo is effective in prevention of recurrence of disease.

Detailed Description

The purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the primary efficacy variable proportion of recurrence-free patients within 48 weeks.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-12
• Primary Completion: 2011-11
• Study Completion: 2012-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

• Diagnosis of left-sided uncomplicated diverticular disease confirmed by ultrasonography or computed tomography
• Presence of at least one diverticulum of the left colon
• Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months
• C-reactive protein (CRP) > upper limit of normal (ULN) at the start of the most recent attack

Exclusion Criteria

• Complicated diverticular disease
• Right-sided diverticulitis
• Previous colonic surgery
• Presence of symptomatic organic disease of the gastrointestinal tract
• Active colorectal cancer or a history of colorectal cancer
• Hemorrhagic diathesis
• Active peptic ulcer disease, local intestinal infection
• Asthma if careful medical monitoring is not ensured
• Abnormal hepatic function or liver cirrhosis
• Abnormal renal function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	-
A	Mesalazine	-

Primary Outcome Measures

Name	Time	Method
Proportion of recurrence-free patients within 48 weeks	48 weeks

Secondary Outcome Measures

Name	Time	Method
Severity of diarrhea	48 weeks
Quality of Life (QoL)	48 weeks
Health assessment	48 weeks
Occurrence of diverticulitis-associated fever	48 weeks
Number of days with left lower quadrant pain	48 weeks
Stool consistency	48 weeks
Time to recurrence
Assessment of efficacy by investigator and patient	48 weeks

Trial Locations

Locations (1)

Evang. Krankenhaus Kalk, Medical department; 🇩🇪 Cologne, Germany